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27 minutes ago
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FDA clears Moderna's new COVID vaccine, but with limits
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has granted an approval to Moderna's next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals. The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying 'risk factors,' the company said Saturday. Moderna CEO Stéphane Bancel called the shot an 'important new tool' to protect people from COVID, noting in a statement that more than 47,000 people in the U.S. died from the disease last year. The FDA based its decision on data from a Phase 3 study that pitted mNexspike against Spikevax, Moderna's original vaccine which is cleared for broad use. Results found mNexspike was 'non-inferior' to Spikevax overall and, in people older than 12 years, slightly more effective on a relative basis. Moderna expects to make mNexspike, which is currently targeted to the JN.1 coronavirus variant, available beginning in the fall. The FDA granted its approval by a May 31 deadline it had set, despite worries that recent moves by Trump administration officials might jeopardize the shot. In May, FDA Commissioner Martin Makary and top vaccine official Vinay Prasad said the agency would require placebo-controlled trials before it cleared any new COVID shots in healthy children and adults. Previously, the FDA has accepted comparative immune data for some decisions, such as for boosters. More recently, Health and Human Services Secretary Robert F. Kennedy Jr. said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children. The CDC has since confused that messaging with a notice indicating the shots remain an option for children. MNexspike's approval is similar to what the FDA recently granted Novavax's protein-based shot Nuvaxovid. That vaccine is also cleared for older adults and those at high risk, while the company is required to conduct an additional study. Messenger RNA shots like Moderna's and Pfizer's Cominarty have appeared to be under higher scrutiny, however. Kennedy has previous questioned the technology, and HHS recently canceled a lucrative contract with Moderna to develop mRNA vaccines for pandemic-prone influenza like bird flu. MRNA shots can be developed and adapted more quickly, traits that allowed Pfizer and Moderna to quickly deliver safe and effective vaccines early on in the pandemic. In a note to clients, Jefferies analyst Michael Yee said the on-time approval is an 'incremental positive' for Moderna. It shows FDA leaders are 'still rational so long as the data packages show good efficacy and is well conducted.' However, there's still some risk Moderna doesn't hit its sales guidance, he added, as vaccination rates remain low. Advisers to the CDC are set to meet in late June to discuss COVID vaccine use recommendations for the coming fall and winter seasons.
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7 hours ago
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At ASCO, Enhertu cements growing role in stomach cancer care
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. AstraZeneca and Daiichi Sankyo's targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy. The finding, detailed Saturday at the American Society of Clinical Oncology's annual meeting, gives physicians a clearer choice for when patients' disease progresses after initial treatment. Data from the trial should also shore up AstraZeneca and Daiichi's market position. Enhertu already won Food and Drug Administration approval for gastric cancer that's positive for a protein called HER2 following first-line treatment with Herceptin, an older HER2-targeting medicine. A so-called antibody-drug conjugate, Enhertu combines the active agent in Herceptin with a chemotherapy toxin, delivering a more potent drug dose directly to HER2-expressing tumor cells than can be administered otherwise. It is one of six blockbuster cancer drugs sold by AstraZeneca and the fastest growing one, with more than $3 billion in 2024 revenue. Cyramza, an Eli Lilly drug, is FDA-approved for gastric cancer that progresses following chemo. Small trials have suggested that, with Herceptin and chemo or just chemo, Cyramza can improve response rates and survival in people whose disease progressed on Herceptin. It is part of the standard second-line regimen Enhertu was tested against. In AstraZeneca and Daiichi's trial, called Destiny-Gastric04, investigators randomized nearly 500 people with HER2-positive cancer who had progressed on Herceptin to receive either Enhertu or Cyramza plus a chemotherapy drug called paclitaxel. The trial measured overall survival as its main goal, with progression-free survival and response rates secondary endpoints. Results showed that Enhertu reduced the risk of death by 30%, extending median survival by 3.3 months to reach 14.7 months, compared to 11.4 months for the Cyramza-chemo combination. The antibody-drug conjugate also reduced the risk of progression by 26%, delaying relapse or death by 1.1 months when compared to Cyramza and chemo. Among Enhertu-treated patients, 44% had their tumors shrink or disappear, significantly more than the 29% of people given Cyramza and chemo. 'This study is practice-validating in the U.S., given [Enhertu's] existing inclusion in guidelines and current use in the second-line setting,' Pamela Kunz, a Yale University specialist in gastrointestinal cancer, said in a press conference ahead of the ASCO meeting. 'It will be practice-changing in many countries outside of the U.S., and will really position [Enhertu] as a preferred second-line treatment.' The trial's findings only apply to HER2-positive patients, which account for as much as one-sixth of the roughly 30,000 new cases of stomach cancer each year. Nearly all trial participants experienced side effects from treatment, although a slightly higher 93% of people who received Enhertu reported side effects compared with 91% on Cyramza. Similar numbers, around half in each group, had side effects judged to be severe or worse. Nearly 14% given Enhertu experienced inflammation or scarring of lung tissue, a known side effect of the drug that previously prompted the FDA to put a 'black box' warning on its label. Kunz said the incidence of lung damage should prompt doctors to 'take note' and 'think about patient selection and consider patient comorbidities' before prescribing Enhertu. With Enhertu's place in the second-line setting now established, AstraZeneca and Daiichi are working to expand its use further by testing it in newly diagnosed people with inoperable HER2-positive tumors. The Destiny-Gastric05 trial is studying it in combination with Merck & Co.'s immunotherapy Keytruda and chemo head-to-head against the FDA-approved regimen of Herceptin, Keytruda and chemo. Results may not be available for three years, however.
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7 hours ago
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Full Arvinas, Pfizer data confirm potential and limits of ‘Protac' drug in breast cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental breast cancer drug from Arvinas and partner Pfizer modestly slowed disease progression in people whose tumors had changes to a specific gene, but did not provide a clear benefit to others who lacked that mutation. Full study results set to be presented Saturday at the American Society of Clinical Oncology's annual meeting provide a clearer picture of the drug's potential — and its limitations — than were available in March, when the companies shared an overview of trial outcomes. While the findings suggest the drug, an oral pill called vepdegestrant, may be a new option for a subset of breast cancer patients, they likely mean its use will remain narrow, should it win an approval. In their Phase 3 trial, Arvinas and Pfizer tested vepdegestrant against the injectable drug fulvestrant in 624 people who had the most common type of advanced breast cancer — tumors positive for estrogen receptors but negative for a protein called HER2. Trial participants had been treated before with hormone therapy and another type of drug known as a CDK4/6 inhibitor. Two-hundred and seventy participants had mutations in the ESR1 gene, which is known to help tumors develop resistance to treatment. The detailed data unveiled Saturday show vepdegestrant extended progression-free survival in people with ESR1 mutations by a median of five months, compared to 2.1 months for those on fulvestrant. Among study participants overall, however, median progression-free survival was similar: 3.8 months on vepdegestrant versus 3.6 months on fulvestrant. PFS measures the time from a treatment response to when either disease progression or death. Speaking in a briefing with reporters ahead of ASCO, Jane Lowe Meisel, co-director of breast medical oncology at the Winship Cancer Institute of Emory University School of Medicine, described vepdegestrant as an 'exciting option.' Yet she noted in a statement how 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Fulvestrant, the drug Arvinas and Pfizer tested vepdegestrant against, is a common treatment for advanced breast cancers that are hormone receptor positive and HER2 negative. The drug, which has been on the market for over two decades, blocks growth signaling to tumors through those hormone receptors. But the therapy has drawbacks, such as monthly intramuscular injections and a range of side effects. Vepdegestrant works differently. The oral drug is what's known as a proteolysis-targeting chimera, or PROTAC. It is designed to break down estrogen receptors, thereby cutting off the signals that promote tumor growth. To date, vepdegestrant is the first PROTAC to advance through Phase 3 testing, and the first of its type to tested in people with advanced breast cancer. Study researchers also measured overall survival but data on that score remain 'immature.' Essentially, too few people have died in the trial to draw conclusions about the statistical differences between the vepdegestrant and fulvestrant groups. Side effects for both treatments were common. Just over one-fifth of participants taking vepdegestrant experienced side effects that were rated severe or life-threatening, compared to 17.6% on fulvestrant. More participants on vepdegestrant — 2.9% — stopped treatment due to side effects at 2.9%, compared to 0.7% among those on fulvestrant. While vepdegestrant held no apparent benefit among the overall population, the drug could still hold promise for breast cancer patients with the ESR1 mutation. Such a role would be valuable as treating ESR1-mutated breast cancer remains challenging. Research led by Memorial Sloan Kettering Cancer Center researchers a decade ago found ESR1 mutations change the shape of the estrogen receptor in such a way that keeps pushing the cancer to grow, even in the absence of an estrogen signal. ESR1 mutations are estimated occur in approximately 40% to 50% of patients who undergo first-line therapy for metastatic breast cancer. Testing for the mutation is now done regularly, but typically occurs only after cancer has progressed or returned. It's become more prevalent since the approval of Orserdu, which is cleared for use in people with ER-positive, HER2-negative breast cancer that is positive for ESR1 mutations. Pfizer and Arvinas in March said they will share data from their study with health regulators in support of potential drug approval applications. But since then, the companies have scaled back their development of vepdegestrant, removing plans for two other Phase 3 trials. Arvinas also cut one-third of its staff. Recommended Reading Arvinas gets positive breast cancer data, but finds differentiation a hard sell
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a day ago
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New Summit data could slow US approval plans for PD-1/VEGF drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn't extend survival, complicating its potential path to approval in the U.S. When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn't meet the threshold for statistical significance, Summit said in a statement Friday. Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is 'necessary' to support a submission. Summit shares fell by nearly 20% early Friday. Ivonescimab is the frontrunner among more than a dozen medicines that simultaneously block the proteins PD-1 and VEGF and are seen as a way to build upon widely used cancer immunotherapies like Keytruda. Its success or failure has broad implications for cancer research, making each study readout a closely scrutinized event among scientists and investors. So far, the results Summit and its China-based partner Akeso have accrued are painting a mixed and incomplete picture. A Phase 3 trial in China in non-small cell lung cancer found the drug cut the risk of disease progression or death in half compared to Keytruda, a striking, first-of-its-kind result that sparked interest and investment in PD-1/VEGF drugs. But ivonescimab hasn't yet clearly extended survival in that same study. Summit's drug also hasn't yet proven superior to the Keytruda-chemotherapy regimen that's standard therapy in many lung cancers. The results accrued so far were from trials in China, too, not the kind of multi-country test the FDA prefers. The data revealed Friday were meant to address one of those issues, proving that the benefits Summit and Akeso have observed in China would be replicated in a broader study population. Summit, for its part, said invonescimab's effects on tumor progression were 'clinically meaningful' in 'both Asia and ex-Asia sub-populations,' and demonstrated the 'consistency' of the drug's benefit in each group. The outcome also closely resembled what Akeso reported in a similar study of EGFR-mutated lung cancer in China. No new safety issues were observed either. The data 'demonstrates the potential benefit ivonescimab has to bring to patients around the world, including the United States,' said Summit chairman and co-CEO Robert Duggan, in a statement. Still, the lack of a clear impact on survival in the trial, at least so far, could slow ivonescimab's path to approval in the U.S. Summit implied its results could improve, as the follow-up time for 'western' patients in its trial was less than the median overall survival figure when data were analyzed. It also noted how no FDA-approved regimens in the setting in which ivonescimab was tested have demonstrated a statistically significant effect on survival. The FDA's insistence on such data, though, 'will weigh into Summit's considerations' as to when it might make a submission, the company said. The agency's 'high bar for demonstrated overall survival benefit make approval less likely,' wrote Leerink Partners analyst Daina Graybosch, in a Friday note to investors. Just this week, Merck and Daiichi Sankyo withdrew an approval application in EGFR lung cancer after a drug they've been developing failed to improve survival in a clinical trial. Summit will disclose specific findings at a future medical meeting. A study evaluating ivonescimab and chemotherapy against Keytruda and chemotherapy in non-small cell lung cancer is ongoing. A readout is expected in 2027, according to a federal database. Recommended Reading New Akeso, Summit data stir debate on PD-1/VEGF drugs
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2 days ago
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Cancer drugmaker iTeos to shut down
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company's assets and intellectual property rights. ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK. The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve. Investors are increasingly scrutinizing 'zombie' biotechs, pressuring their executive teams to shut down and return capital to shareholders after their primary development efforts fail. Typically, struggling companies have turned to mergers or pivoted to new programs to justify holding onto their cash reserves. Activist investors and analysts have argued they should give that money back to their investors instead. A new investment fund launched in April with the intention of liquidating billions of dollars in cash "trapped" on the balance sheets of nearly 300 public biotechs whose share prices have fallen significantly. 'Cash that was raised through an efficient capital process to fund specific projects ... is now being allocated by a few insiders and spent on programs that investors are not willing to support,' Cantor Fitzgerald analyst Eric Schmidt wrote in a February note explaining how the goals of executive teams and investors can diverge in the wake of clinical setbacks. He specifically highlighted biotechs Cargo, BioAge Labs and Keros Therapeutics. ITeos fits a similar mold. It developed an immunotherapy with Pfizer in the mid-2010s, but the pharma giant handed back rights to development in 2018 after the drug's promise faded. A few years later, iTeos brokered a deal with GSK to develop a so-called TIGIT drug for use in combination with cancer immunotherapies. Testing of that candidate was stopped in mid-May after study results showed the drug regimen failed to significantly delay tumor progression in non-small cell lung cancer. Data showed a 'trend below the meaningful threshold' for drug responses in study participants with other cancers, iTeos said. At the time, iTeos CEO Michel Detheux said: 'We believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets.' According to a regulatory filing Wednesday, iTeos plans to spend as much as $24.7 million in severance and other layoff costs, as well as another $11.1 million to wind down clinical development activities and terminate leases and other contracts. It expects to complete that by the third quarter of 2025. As of March 31, iTeos held $156.5 million in cash and cash equivalents. Recommended Reading iTeos, GSK to shelve TIGIT drug after study setback Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
